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News Breaks | | | | February 8, 2013 | | 06:36 EDT |  | IVC | Invacare reports Q4 EPs (6c), may not be comparable to consensus 25c
Reports Q4 revenue $360.4M, one estimate $422.7M. Q4 EPS negative impacted by by incremental regulatory and compliance costs related to quality system improvements of $3.2M of after-tax expense, reduced gross margin, volume declines and a higher effective tax rate on adjusted pre-tax earnings. | |
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| May 13, 2013 | | 19:42 EDT |  | IVC | Invacare reports FDA acceptance of audit related to consent decree
Invacare announced that the United States Food and Drug Administration has found acceptable the company’s first certification audit relating to the qualification and validation documentation for equipment and processes at the Taylor Street manufacturing facility in Elyria, Ohio. This acceptance permits the company’s Taylor Street facility to resume manufacturing and distributing parts, components, accessories and subassemblies to Invacare facilities other than the Taylor Street or corporate facilities, for further manufacturing or to provide service related to medical devices manufactured at those other Invacare facilities. Of the two remaining certification audits, the second audit relating to the company’s design control systems is currently being reviewed by the FDA. Once it receives the FDA's approval on the second certification report, the company may resume design activities, which will enable it to refocus its engineering resources on new product development. The final, third-party certification audit is a comprehensive review of the company's compliance with the FDA's quality system regulation at the impacted Elyria facilities. That audit is underway. | |
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